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FDA issues QIDP, Fast Track designations to novel IV antibacterial for C. difficile infection

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The FDA has granted Qualified Infectious Disease Product and Fast Track designations to MCB3837, Morphochem’s novel intravenous antibacterial candidate for treating Clostridium difficile infection, the manufacturer announced.

“MCB3837 is a water-soluble injectable small-molecule prodrug of the active substance MCB3681,” which may selectively target C. difficile pathogens based on its strong pharmacodynamics effects, narrow Gram-positive spectrum and favorable effects on commensal flora, according to a press release.

Three phase 1 clinical studies have shown MCB3837/MCB3681 to be safe and tolerable. Further, healthy volunteers in a multiple-dose phase 1b trial had high fecal concentrations of MCB3681, with selective effects on clostridia and other Gram-positive species that spared beneficial Gram-negative species. In addition, preclinical studies showed “remarkable Gram-positive antimicrobial activity against C. difficile pathogens including the highly virulent BI/NAP1/027 strain, with no cross-resistance to any established class of antibacterial.”

“After the U.S. FDA’s acceptance of Morphochem’s IND in June, we are glad to have now received both QIDP and Fast Track designation for MCB3837,” Thomas Kapsner, MD, Morphochem’s CEO, said in the press release. “These designations will help us to expedite the development of this promising IV compound for the many severely ill CDI patients who cannot be treated orally. By providing an effective IV therapy, we aim to improve the prospects and quality of life of these patients.”

The Qualified Infectious Disease Product (QIDP) designation, under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, provides incentives for developing new antibacterials, like priority review and five extra years of marketing exclusivity, while the Fast Track designation permits more frequent communication with the FDA, which can lead to earlier drug approval and access.

The company plans to begin a phase 2 proof-of-concept clinical trial in patients with severe CDI in the second half of 2016, according to the press release.

Disclosures: Kapsner is employed by Morphochem.